CALAMINE - ferric oxide red lotion 
Dolgencorp, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Rexall  063.001 063AA

Active ingredients

Calamine 8%
Zinc oxide 8%

Purpose

skin protectant

Use

dries the oozing and weeping of poison:•ivy • oak • sumac

Warnings

For external use only

When using this product

do not get into eyes

Stop use and ask a doctor if

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Directions

• shake well before using • apply as needed

Other information

store at 59⁰ - 86⁰ F

Inactive ingredients

bentonite magma, calcium hydroxide, glycerin, purified water

Visit us at: Rexall.com

or call 1-866-4REXALL

DISTRIBUTED BY DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072 USA

principal display panel

Since 1903
REXALL

Calamine Lotion
Calamine Topical Suspension USP
• Poison ivy, oak and sumac drying lotion
• Skin protectant

6 FL OZ (177 mL)

image description

CALAMINE  
ferric oxide red lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-063
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED80 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE80 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
bentonite (UNII: A3N5ZCN45C)  
CALCIUM HYDROXIDE (UNII: PF5DZW74VN)  
GLYCERIN (UNII: PDC6A3C0OX)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-063-30177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/13/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/13/2009
Labeler - Dolgencorp, LLC (068331990)
Registrant - Vi Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC790752542manufacture(55910-063)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC088520668manufacture(55910-063)

Revised: 4/2022
Document Id: b6cb653a-7e8e-4e72-8b3c-bddd9f8ec9eb
Set id: c38c77fd-abbf-4c87-a9c0-a0e21ed3f97d
Version: 16
Effective Time: 20220407
 
Dolgencorp, LLC